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CT Inspection -11-2-2011

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					                                               Effective Date:
                CLINICAL TRIAL INSPECTION          01-11-2010




GUIDANCE ON CLINICAL TRIAL
                     INSPECTION




 CENTRAL DRUGS STANDARD CONTROL ORGANIZATION

      DIRECTORATE GENERAL OF HEALTH SERVICES

         MINISTRY OF HEALTH & FAMILY WELFARE

                          GOVT. OF INDIA

                          November-2010




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                                                                           INDEX
#    Content                                                                                                                                                           Page No.
1.   ABBREVIATIONS..............................................................................................................................................          3
2.   OBJECTIVES.....................................................................................................................................................      4
3.   SCOPE AND EXTENT OF THE PROGRAMME...............................................................................................                                     4
4.   PLANNING FOR INSPECTION.........................................................................................................................                     4
     4.1 SELECTION OF STUDIES .........................................................................................................................                   5
     4.2 INSPECTION ASSIGNEMENTS ................................................................................................................                         5
     4.3 PREPARING FOR INSPECTION.................................................................................................................                        5
     4.4 SCHEDULING THE INSPECTION...............................................................................................................                         6
5.   CONDUCTING THE INSPECTION:...................................................................................................................                        6
     5.1 CLINICAL TRIAL SITE...............................................................................................................................               6
            5.1.1 OPENING INTERVIEW: ..................................................................................................................                   6
            5.1.2 ORGANISATION AND DELEGATION OF RESPONSIBILITIES.....................................................                                                    7
            5.1.3 STUDY PROTOCOL .......................................................................................................................                  8
            5.1.4 SUBJECT RECORD & INFORMED CONSENT ..............................................................................                                        9
            5.1.5 SOURCE DOCUMENTS AND CASE RECORD FORM (CRF) ........................................................                                                    9
            5.1.6 ETHICS COMMITTEE (EC)/INDEPENDENT ETHICS COMMITTEE (IEC).....................................                                                          10
            5.1.7 SPONSOR ....................................................................................................................................           11
            5.1.8 TEST DRUG ACCOUNTABILITY .........................................................................................                                     11
            5.1.9 RECORD RETENTION ..................................................................................................................                    12
            5.1.10 CONCLUDING THE INSPECTION .........................................................................................                                   12
     5.2 INSPECTION OF CRO/SPONSOR.............................................................................................................                          12
            5.2.1 DOCUMENTS SUBMITTED TO CDSCO AND REGULATORY APPROVALS OBTAINED ...........                                                                             12
            5.2.2. ORGANISATION AND PERSONNEL .............................................................................................                              13
            5.2.3 SELECTION AND MONITORING OF INVESTIGATORS ................................................................                                             14
            5.2.4 QUALITY ASSURANCE (QA)..........................................................................................................                       15
            5.2.5 ADVERSE EVENTS (AE) REPORTING .........................................................................................                                15
            5.2.6 DATA COLLECTION AND HANDLING ............................................................................................                              15
            5.2.7 ELECTRONIC RECROD AND CLINIAL DATABASE......................................................................                                           16
            5.2.8 DATA COLLECTION .......................................................................................................................                16
            5.2.9 COMPUTEIZED SYSTEM SECURITY.............................................................................................                               16
            5.2.10 INVESTIGATIONAL PRODUCT (IP)..............................................................................................                            17
6.   REPORTING OF INSPECTION .......................................................................................................................                     17




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1 ABBREVIATIONS




 AE             Adverse events

 CRO            Clinical Research Organisation

 CRF            Case Record Form

 CT             Clinical Trial

 CV             Curriculum Vitae

 EC             Ethics Committee

 ICF            Informed Consent Form

 IEC            Institutional Ethics Committee

 IP             Investigational Product

 SOP            Standard Operating Procedure

 SLA            State Licencing Authority




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                   CLINICAL TRIAL INSPECTION                                     01-11-2010



                   CLINICAL TRIAL INSPECTION PROGRAMME
2   Objectives :

    The aims of the programme are:

    a.     To verify GCP compliance to protect the rights, safety and well being of
           the subjects involved in clinical trial

    b.     To verify the credibility and integrity of clinical trial data generated

    c.     To verify the compliance with various regulatory provisions as per
           Drugs & Cosmetics Rules

           The purpose of this programme is to provide direction to
    inspectors/CDSCO officers for conducting inspection of site of clinical trial,
    sponsor / CRO’s facilities involved in clinical trial and information to
    investigators, sponsor/ CRO’S about procedures for inspection and follow up
    of action.



3   Scope and extent of the programme:

    Clinical trial inspection programme covers all clinical trial sites and sponsor /
    CRO’s facilities involved in clinical trial of drugs including biological and
    medical device covered under Drugs & Cosmetics Act.




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4.   Planning for Inspection:

     Inspection can be conducted before, during or after a clinical trial is
     completed.

     4.1    Selection of studies:

                Inspection can be carried out as a routine surveillance or for any
                specific cause(s).Study may be selected for inspection based on,
                but not restricted to the following criteria:
                  4.1.1    Nature of study
                  4.1.2    For regulatory decision based on clinical trial data
                  4.1.3    Data irregularities
                  4.1.4    Complaints
                  4.1.5    Vulnerability of subjects
                  4.1.6    Number of CT including number of subject enrolled at a
                           particular site


     4.2    Inspection assignments:

                CDSCO HQ will issue instruction to the CDSCO Officers
                /Inspectors to conduct the inspection identifying the Clinical trial,
                name, address, contact number of clinical trial site, sponsor /
                CRO’s facilities to be inspected. It may also identify the type and
                purpose of the inspection and provide background materials like
                study protocol, CRF etc.


     4.3    Preparing for inspection:


                The inspector shall go through the information provided by CDSCO
                HQ and develop a plan for conducting the inspection.




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     4.4    Scheduling the inspection:

                      Inspection of clinical trial site would generally be pre-announced
                      to ensure availability of the Investigator / Sub- Investigator and
                      other personnel along with study records at the time of the
                      inspection.
                      The date of inspection and other arrangements would be
                      finalised by the CDSCO Officers / Inspector(s) in coordination
                      with the investigator /sponsor/ CRO.
                      Under some specific circumstances unannounced inspection of
                      clinical trial sites can be carried out as per the direction of
                      CDSCO HQ.
                      Inspection of CRO/Sponsor can be conducted without prior
                      notice.

5.   Conducting the inspection:
      5.1 Clinical Trial Sites:

                    The inspection includes verification of essential documents to
                    determine whether the trial related activities were in accordance
                    with the protocol, GCP guidelines published by DGHS, Govt. of
                    India and Schedule Y as well as other applicable regulatory
                    requirements. When inspection is carried out after completion of
                    the clinical trial, it will include comparison of data generated by the
                    sponsor with source documents at the clinical trial sites and Case
                    Record Form (CRF) in the investigator’s files. If it is a routine
                    surveillance or “for cause” inspection of an ongoing clinical trial,
                    the comparison will generally include source documents and CRF.


       5.1.1 Opening interview:
                Inspector should meet investigator / key person of Sponsor and
                present his / her identity card. The inspector should provide verbal
                summary of methods and procedures to be followed during the
                inspection.




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            During opening interview following main activities should be found
            out:
        5.1.1.1     Investigator prior education and GCP experience, GCP
                    training provided by the sponsor.
        5.1.1.2     Who did what, when, where and how with respect to
                    following:
                  Obtaining Informed consent of subjects,
                  Screening and admission of subjects to the study,
                  Receipt, handling, administration, return of investigational
                     product,
                  Collection and analysing of data,
                  Recording, transcribing and reporting of data to sponsor,
                  Archiving the data

        5.1.1.3      How did the investigator identify the subjects for the study,
        5.1.1.4      Date of enrolment first and last subject
        5.1.1.5      About Ethics Committee the site is using
        5.1.1.6      Whether the investigator has copies of protocol,
                     permission from CDSCO, undertaking by the investigator
                     etc.
        5.1.1.7      Information about unexpected and serious adverse events
                     (if any) occurred at the site,
        5.1.1.8      Information about monitoring/auditing of the site by
                     sponsor/CRO.

                     During the interview other relevant facts may also be
                     found out.

  5.1.2 ORGANIZATION & DELEGATION OF RESPONSIBILITIES:

       Inspector shall verify / obtain following:

        5.1.2.1      Brief about study site.
        5.1.2.2      Status of the study.
        5.1.2.3      Whether investigator has agreement with sponsor for the
                     study.
        5.1.2.4      Whether financial & Confidentiality agreement with
                     Investigator and concerned laboratory (ies) in place.
        5.1.2.5      In Investigator undertaking protocol title, Investigator’s
                     name, address, telephone no of site, qualification, Name
                     & address of laboratories, Name of Sub-Investigator etc
                     are in-compliance with Schedule Y of Drugs & Cosmetics
                     Rules 1945.

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          5.1.2.6           Obtain list of all clinical trials performed by investigator.
                            The list should have information such as
                           Protocol Number
                           Protocol Title
                           Name of Sponsor/CRO
                           Study date

          5.1.2.7           Determine whether authority for conducting           various
                            Clinical trial related activities were delegated properly by
                            the Investigator to the competent personnel so that
                            investigator was able to supervise the study adequately.
                            Obtain a list of personnel with delegated activity.

          5.1.2.8           Documents following;

                           Date of EC / IEC approval including initial review of
                            protocol, amendment, ICD etc.
                           Date of screening of first subject,
                           Date of signing ICF by the first subject
                           Date of first administration of IP,
                           Date of last follow up of any subject,

          5.1.2.9           List the name and address of facilities involved in
                            laboratory test required by protocol. Verify accreditation
                            status and adequacy of these facilities to perform the
                            specified test,
          5.1.2.10          Obtain a copy of site enrolment log,
          5.1.2.11          Determine whether SOP’s for various activity are
                            established and documented,


  5.1.3    Study Protocol
          5.1.3.1           Determine if, there are any difference between protocol
                            provided to CDSCO and the protocol in the Investigator’s
                            file with respect to following

                           Version number and effective date
                           Eligibility of Subject (Inclusion/ Exclusion Criteria)
                           No of Subject
                           Dosage
                           Route of administration
                           Frequency of dosage
                           Randomisation & Blinding process


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                       Verify whether Investigator follow the protocol as
                        approved
                       Version number and EC approval of amendments


  5.1.4    Subject record & Informed consent:

          5.1.4.1        Review the Informed Consent Form (ICF) signed by the
                        subjects. If the number of subjects at site is relatively
                        small (e.g.20or less) 100% of the ICF can be reviewed.
                        Determine the following:
          5.1.4.2       whether ICF have all the elements enlisted in Appendix V
                        of Schedule Y,
          5.1.4.3       whether IC has been obtained from each subjects prior to
                        participation of the subject in the study,
          5.1.4.4       whether signature/thumb impression of the subjects have
                        been affixed with date,
          5.1.4.5       whether in case of illiterate subjects or illiterate
                        representative of a subject, there are signature and details
                        of an impartial witness,
          5.1.4.6       Have witness/ signature been personally dated,
          5.1.4.7       Have patient signature been personally dated?
          5.1.4.8       Has the dated signature of the designated person for
                        administering informed consent (IC) been affixed?
          5.1.4.9       Is the designated person for administering IC medically
                        qualified?
          5.1.4.10      If IC has been administered by a designated person who
                        is not medically qualified, is there evidence that subject's
                        queries of a medical nature were answered by a medically
                        qualified person or the investigator?
          5.1.4.11      Is the completed ICF signed and dated by the
                        investigator?


  5.1.5    Source Documents and Case Record Form

          5.1.5.1       Verify condition, completeness, legibility, accessibility of
                        the investigators source data file.
          5.1.5.2       Determine whether subjects who were enrolled and /or
                        completed the study meet inclusion and exclusion criteria;
          5.1.5.3       Determine whether subject received the test drug with
                        respect to dose and frequency specified according to the
                        protocol;



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          5.1.5.4   Determine whether safety/ efficacy end point data was
                    collected and reported in accordance with the protocol;
          5.1.5.5   Does medical record mentions subject ID/ name /hospital
                    registration number / and indication that subjects are
                    participating in a clinical trial
          5.1.5.6   Whether all adverse events were reported in CRF;
          5.1.5.7   Compare the source document with CRF and determine
                    whether source data have been correctly transcribed in
                    CRF;
          5.1.5.8   Verify whether all SAE’s have been reported to the
                    sponsor (within 24 hours) and EC (within 7 working
                    days);
          5.1.5.9    Verify whether adequate medical care have been given to
                    the subject especially in the event of inter current illness,
                    adverse events including abnormal lab parameters;

  5.1.6   Ethics Committee (EC) / Independent Ethics
          Committee (IEC):

          5.1.6.1   Identify the name , address of the EC/ IEC in the approval
                    letter and compare it with that stated in investigators
                    undertaking ;
          5.1.6.2   Verify if IEC approval letter mention study code , Protocol
                    title and version number of the protocol, list of other
                    documents reviewed, list of members present at the
                    meeting, quorum of five members as specified in
                    Schedule Y satisfied, date, time , venue of the meeting,
                    signature and date of member secretary / Chairman;
          5.1.6.3    In case the site does not have an IEC, verify whether
                    following are in place:
                          Statement of the investigator / institution that
                           approval granted by another IEC would be abided
                           by & statement from the approving IEC that they
                           would take responsibility for ongoing supervision of
                           the site;
                          Has the investigator submitted reports of all SAEs
                           to the IEC and apprised the EC/IEC about the trial
                           progress?




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  5.1.7 Sponsor:
          Verify/ determine:

         5.1.7.1   Whether a clinical trial Investigators agreement has been
                   signed for this study with the sponsor;
         5.1.7.2   Whether investigator maintains copies of all reports
                   submitted to the sponsor;
         5.1.7.3   Whether all SAE are reported to sponsor within 24 hours;
         5.1.7.4   Whether all CRFs were submitted to sponsor after
                   completion of study;
         5.1.7.5   Whether all dropouts and reasons thereof were reported
                   to sponsor;
         5.1.7.6   The method and frequency of monitoring the progress of
                   the study by the sponsor;
         5.1.7.7   Whether a log of onsite monitoring visit is maintained at
                   the site;

  5.1.8 Test Drug Accountability:

         5.1.8.1   Review individual subject record to verify the correct dose
                   administration with respect to dose, frequency, route of
                   administration;
         5.1.8.2   Determine whether unqualified /unauthorised persons
                   administered/dispensed the test drug
         5.1.8.3   Determine whether adequate record of qty. of test drug
                   received , dispensed/ destroyed/returned is maintained ;
         5.1.8.4   Determine whether storage condition/monitoring method
                   are as per protocol/recommendation;
         5.1.8.5    Whether trial medication are maintained under controlled
                   access;
         5.1.8.6   Have un-used trial medications been returned to the
                   sponsor or disposed of according to protocol? In case of
                   destruction at site, is there a certificate of destruction on
                   file?

         5.1.8.7   Are the drugs dispensing records being maintained
                   properly?
         5.1.8.8   Are the records for reconciliation of all IPs received from
                   the sponsor maintained?




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  5.1.9 Record retention:

         5.1.9.1      Is adequate space available at the site for retention of
                      documents
         5.1.9.2      Determine whether documents are maintained properly
                      and for the period as specified and necessary measures
                      have been taken for accidental and premature
                      destruction;
         5.1.9.3      Determine who maintained custody of the documents and
                      means for assuring prompt action;

  5.1.10 Concluding the Inspection:

                The inspector should conclude the inspection with final
                discussion with the Investigator. During discussion the inspector
                should explain inspection finding .The inspector may also issue
                a list of observation at the conclusion of inspection.


  5.2    Inspection of CRO/Sponsor
                The inspection includes verification of essential documents to
                compare practice and procedure followed by the CRO/Sponsor
                to that committed in the clinical trial application and GCP
                guidelines published by DGHS, Govt. of India and Schedule-Y
                as well as other applicable regulatory requirements. Inspection
                of CRO/Sponsor can be conducted without prior notice.
                During inspection following aspects may be verified.

  5.2.1 Documents submitted to CDSCO and regulatory
         approvals obtained.

         5.2.1.1      Clinical Trial application and DCGI approval letter
         5.2.1.2      Import license application(Form 12) and import licence
                      obtained (Form 11)Copy of license in Form 29 from
                      (State Licencing Authority) SLA (in case of manufacture
                      of test drugs)
         5.2.1.3      Export NOC for biological samples
         5.2.1.4      List of investigators
         5.2.1.5      Investigator Undertaking        (as per Appendix VII of
                      Schedule Y)
         5.2.1.6      Investigator's brochure
         5.2.1.7      Protocol and Protocol amendments
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         5.2.1.8    Patient Information Sheet and Informed Consent Form
         5.2.1.9    Case Record Form
         5.2.1.10   Ethics Committee approval and notifications to CDSCO
         5.2.1.11   Unexpected and Serious Adverse Event Reports
         5.2.1.12   Study report


  5.2.2 Organisation and personnel:

         5.2.2.1    Company profile and overall structure,
         5.2.2.2    Organization chart for management of the clinical trial,
                    Structure and responsibilities for all activities involving
                    investigational products. Departments, functions, and key
                    personnel responsible for Protocol development,
                    Investigator's brochure, Case Record Form, Informed
                    consent form (ICF), translations and amendments
                    ,Selection of investigators, Regulatory approval, Ethics
                    Committee (EC) approval, Monitoring, Quality assurance
                    Adverse Event (AE) Reporting, Data Management ,
                    Statistical Analysis, Electronic Records/Clinical Database,
                    Clinical Supplies-Investigational Products (IP) Archival.
         5.2.2.3    Identify and determine the personnel responsible for
                    following
                          Authority to review and approve study documents
                          For final evaluations and decisions in the review of
                            study
                          For obtaining & reviewing adverse events and
                            reporting to CDSCO
                          Monitors/CRO(s) with job descriptions and
                            qualifications
                          Job description of key stake holders
                          Verify clinical personnel training record
                          To obtain a list of external service providers and
                            contractors and documentation of the service they
                            provide.
                          Verify      that   SOPs      followed      for    various
                            responsibilities and clinical trial related activities.




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  5.2.3 Selection and monitoring of investigators

         5.2.3.1   Obtain list of all investigators along with Investigator
                   Undertaking, Signed Investigator Agreements
         5.2.3.2   Criteria for selection of sites
         5.2.3.3   Information provided to sites viz.
                    Informed consent form, Protocol, Reports/publications of
                   previous trials, Investigator's Brochure, Product labelling,
                   Training, All versions and updates etc.
         5.2.3.4   Investigator’s non-compliance (If any)
                         Deviations from CDSCO regulations
                         Deviations form protocol
                         How sponsor handles serious deviations from
                           approved protocol or Schedule Y /Indian GCP
                           Guidelines.
         5.2.3.5   Steps for correction:
                         Verify whether any investigators terminated?
                           Review monitoring reports reported to CDSCO,
                         Any Non-compliant investigator /terminated?
                           Reasons?
         5.2.3.6   Selection of monitor:
                         List all monitors for study duration
                         Selection criteria for monitors
                         Job descriptions/responsibilities
                         Qualifications
                         Training Records and CVs
                         Reporting structure
                         Monitoring SOP Frequency, scope and process,
                           Obtain a copy of SOP and check compliance, If no
                           SOPs, interview monitors to check how monitoring
                           was done , Monitoring Plan, Monitoring Reports
         5.2.3.7   Review the Pre trial and periodic trial visit report in respect
                   of following content:
                         Process of verifying compliance to protocol
                         Process of verifying investigator responsibilities
                         Ethics Committee Approvals Amendments/Re-
                           approval Communication-progress reports/SAEs
                           etc Validity/Completeness
                         Informed Consents, Confirmation of consent and
                           process of consent.
                         Use of IEC approved forms.
                         Adequacy of consent documentation,
                           completeness

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                        Which CRFs were compared to source docs?
                         When and who verified CRFs against source data
                         (hospital records, office charts, laboratory reports,
                         etc.) at the study site. Form for data verification
                        Check copy of any SOPs and guidelines for data
                         verification
                        Data correction handling, Compliance to Monitoring
                         Plan, Frequency, Follow up etc.

  5.2.4 Quality Assurance (QA):

         5.2.4.1   Verify SOP for QA audits and operation of quality
                   assurance unit
         5.2.4.2   Describe how the audit and monitoring are separated
         5.2.4.3   Obtain list of audited trial

  5.2.5 Adverse events reporting:

         5.2.5.1   Verify sponsor’s method for following up of adverse
                   events and for dissemination of AE information to others
                   Investigators:
         5.2.5.2   Obtain list of SAE reported, Including death
         5.2.5.3   Verify the timeline for reporting the SAE to CDSCO and
                   other Investigators /EC;

  5.2.6 Data collection and handling

         5.2.6.1   Study tabulations: List of all studies for marketing
                   Authorization
         5.2.6.2   Data Tabulations: Number of subjects. Verify if number in
                   CT application same as marketing Authorization
                   application(compare to CRFs submitted)
         5.2.6.3   If any subjects not included in the marketing Authorization
                   application? Why not included?
         5.2.6.4   Review of SOPS to verify compliance to assure the
                   integrity of safety and efficacy data collected from clinical
                   investigators
         5.2.6.5   Verify that the SOPs were followed and document any
                   deviations
         5.2.6.6   Deviations/Data queries resolutions
         5.2.6.7   Statistical processes
         5.2.6.8   Primary endpoints Compare the tabulations with CRFs
                   and source documents
         5.2.6.9   Record retention


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  5.2.7 Electronic Record and Clinical database:

         5.2.7.1   Person responsible for designing and developing data
                   base
         5.2.7.2   Can it be modified, or has it been modified? If so, by
                   whom?
         5.2.7.3   If the clinical investigator can modify it, how would the
                   sponsor be aware of any changes?
         5.2.7.4   Validation :Person responsible, Process, Documentation
                   of process
         5.2.7.5   Error logs maintained for errors in software and systems?
         5.2.7.6   Do error logs identify corrections made?


  5.2.8 Data collection:
        Following aspects may be verified:

         5.2.8.1   Responsibilities : Authorization to access the system, to
                   enter data and to change data
         5.2.8.2   Use of electronic data capture or data transcription from
                   paper CRFs into an electronic record
         5.2.8.3   Audit trail : to record Changes to electronic records,
                   Person Responsible for the change and Time of the
                   change
         5.2.8.4   Process of data transmission from the clinical investigator
                   to sponsor or CRO

  5.2.9 Computerized System Security:
        Following aspects may be verified:

         5.2.9.1   Management of system access e.g. access privileges,
                   authorization/de-authorization      procedures,      physical
                   access controls
         5.2.9.2   Records of authorized personnel , Names, Titles.
                   Description of their access privileges
         5.2.9.3   Access methods e.g., identification code/password
                   combinations, tokens, biometric signature, electronic
                   signatures, digital signatures
         5.2.9.4   Data security in case of disasters, e.g., power failure
         5.2.9.5   Contingency plans and backup files
         5.2.9.6   Controls in place to prevent data from being altered,
                   browsed, queried, or reported via external software
                   applications that do not enter through the protective
                   system software

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  5.2.10 Investigational Product(IP):
        Following aspects may be verified:

         5.2.10.1     Transferred data from central lab to sponsor
         5.2.10.2     Integrity Procedures to ensure integrity of IP from
                      manufacturing to receipt by the clinical investigator.
         5.2.10.3     If IP met required release specifications by review of the
                      Certificate of Analysis?
         5.2.10.4     Storage of IP and the conditions of storage
         5.2.10.5     Process of verification of IP integrity during shipment to
                      investigator.
         5.2.10.6     IP label
         5.2.10.7     If the test article was recalled, withdrawn, or returned?

         5.2.10.8     Accountability:
                      Following aspects may be verified:
                           Names and addresses of clinical investigators
                            receiving IP Shipment, date (s), quantity, batch
                            number.
                           Final disposition of the test article.
                           Detailed audit if serious violations are suspected.
                           Sufficient records to reconcile IP usage (compare
                            the amount shipped to the investigators to the
                            amount used and returned or disposed of).
                           Check whether all unused or reusable supplies of
                            IP returned to the sponsor when either the
                            investigator(S)     discontinued       or   completed
                            participation in the clinical investigation, or the
                            investigation was terminated. If the test article was
                            not returned to the sponsor, describe the method of
                            disposition and determine if adequate records were
                            maintained.

6. Reporting of inspection
                The Inspection should be documented in writing in both during
                and after inspection. After the inspection a narrative report
                containing details of inspection finding should be prepared and
                submitted to CDSCO (HQ).


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